Amipride
Generic Name
Amisulpride
Manufacturer
Various manufacturers
Country
Global
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| amipride 100 mg tablet | ৳ 30.00 | ৳ 300.00 |
Description
Overview of the medicine
Amipride 100 mg Tablet contains Amisulpride, an atypical antipsychotic medication used to treat schizophrenia in adults and adolescents aged 15 years and older.
Uses & Indications
Dosage
Adults
For acute psychotic episodes (predominantly positive symptoms): 400-800 mg/day orally, divided into two doses. Maximum recommended dose is 1200 mg/day. For predominantly negative symptoms: 50-300 mg/day orally, as a single dose. For mixed positive and negative symptoms: 400-800 mg/day orally, divided into two doses.
Elderly
Lower doses may be considered with careful monitoring due to potential for decreased renal function and increased sensitivity. Initiate with lower doses and titrate gradually.
Renal_impairment
Creatinine clearance 30-60 mL/min: half the usual dose. Creatinine clearance < 30 mL/min: one-third the usual dose. Not recommended for severe renal impairment (CrCl < 10 mL/min).
How to Take
Take orally with or without food. For daily doses exceeding 400 mg, the dose should be divided into two administrations. Swallow the tablet whole with water.
Mechanism of Action
Amisulpride acts as a selective antagonist of D2 and D3 dopamine receptors in the limbic system. At low doses, it preferentially blocks presynaptic D2/D3 autoreceptors, leading to increased dopamine release, which can improve negative symptoms. At higher doses, it blocks postsynaptic D2/D3 receptors, reducing positive symptoms.
Pharmacokinetics
Onset
Clinical effects typically observed within days to weeks, with full therapeutic effect often taking several weeks.
Excretion
Mainly excreted unchanged in the urine (approximately 50% of an intravenous dose, and 60% of an oral dose). Renal clearance is approximately 20 L/h.
Half life
Approximately 12 hours (biphasic elimination with an initial elimination half-life of 2-3 hours and a terminal half-life of 12 hours).
Absorption
Rapidly absorbed, with two absorption peaks (1 hour and 3-4 hours after administration). Bioavailability is approximately 48%.
Metabolism
Minimally metabolized in the liver; two inactive metabolites (sulfoxide derivatives) identified, accounting for less than 1% of the dose.
Side Effects
Contraindications
- Known hypersensitivity to Amisulpride or any component of the tablet.
- Prolactin-dependent tumours (e.g., prolactinoma of the pituitary gland, breast cancer).
- Phaeochromocytoma.
- Concomitant use with certain dopaminergic agonists (e.g., cabergoline, quinagolide).
- Children below 15 years of age.
- Severe renal impairment (CrCl < 10 mL/min).
Drug Interactions
Levodopa
Antagonism of levodopa effects by amisulpride; concomitant use is generally contraindicated.
Antihypertensives
Enhanced hypotensive effect, especially orthostatic hypotension.
Other antipsychotics
Potential for additive side effects, especially extrapyramidal symptoms or QT prolongation.
Dopaminergic agonists (e.g., bromocriptine, ropinirole)
Mutual antagonism; avoid concomitant use due to reduced efficacy of both drugs.
CNS depressants (e.g., alcohol, benzodiazepines, opioids, antihistamines)
Increased central nervous system depression, leading to increased sedation, dizziness.
Drugs that prolong the QT interval (e.g., antiarrhythmics Class IA and III, certain antibiotics like erythromycin, moxifloxacin, tricyclic antidepressants, some antimalarials)
Increased risk of cardiac arrhythmias, including Torsade de Pointes. Concomitant use should be avoided.
Storage
Store below 30°C (86°F) in a dry place. Protect from light and moisture. Keep out of the reach and sight of children. Do not use after the expiry date printed on the carton.
Overdose
Symptoms of overdose typically include drowsiness, sedation, hypotension, severe extrapyramidal symptoms, and coma. QT prolongation and ventricular arrhythmias, including Torsade de Pointes, have also been reported. Management is primarily supportive, including close monitoring of vital signs and cardiac rhythm (ECG), activated charcoal to reduce absorption, and symptomatic treatment. There is no specific antidote.
Pregnancy & Lactation
Pregnancy category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. Not recommended during breastfeeding due to excretion into breast milk and potential for adverse effects on the infant. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2 to 3 years from the date of manufacture, when stored under recommended conditions. Check the expiry date on the packaging.
Availability
Pharmacies, hospitals
Approval Status
Approved by regulatory authorities
Patent Status
Patent expired, available as generic
Clinical Trials
Amisulpride has been extensively studied in numerous clinical trials for its efficacy and safety in the treatment of schizophrenia, demonstrating significant improvement in both positive and negative symptoms. Research has also explored its use in other conditions, though its primary approved indication remains schizophrenia. Ongoing post-marketing surveillance continues to gather data on long-term effects and rare adverse events.
Lab Monitoring
- Serum prolactin levels (especially if symptoms like amenorrhea, galactorrhea, sexual dysfunction occur).
- Blood glucose levels (fasting glucose, HbA1c) periodically, especially in patients with diabetes or risk factors for diabetes.
- Lipid profile (total cholesterol, LDL, HDL, triglycerides) periodically.
- ECG (before and periodically during treatment, especially with risk factors for QT prolongation).
- Liver function tests (ALT, AST, ALP) periodically.
- Renal function tests (creatinine, BUN) periodically, especially in elderly or renally impaired patients.
- Complete Blood Count (CBC) with differential, particularly if fever or signs of infection develop.
Doctor Notes
- Monitor patients for emergence or worsening of extrapyramidal symptoms, particularly at higher doses; consider dose reduction or addition of anticholinergic agents if severe.
- Assess for metabolic changes at baseline and periodically during treatment, including weight, blood glucose (fasting), and lipid profiles. Counsel patients on lifestyle modifications.
- Regularly evaluate cardiac status, including baseline and periodic ECG, especially in patients with pre-existing cardiac conditions, family history of QT prolongation, or concomitant use of QT-prolonging drugs.
- Educate patients on potential side effects, the importance of adherence, and the risks of abrupt discontinuation.
- Exercise caution in patients with Parkinson's disease, as amisulpride may worsen symptoms.
- Avoid use in patients with severe renal impairment (CrCl < 10 mL/min) and adjust dose in moderate renal impairment.
Patient Guidelines
- Do not stop taking this medicine suddenly without consulting your doctor, as abrupt discontinuation can lead to withdrawal symptoms or relapse.
- Inform your doctor about all other medications, over-the-counter drugs, herbal products, and supplements you are taking to avoid potential drug interactions.
- Avoid alcohol and other CNS depressants while on this medication, as they can enhance sedative effects.
- Report any unusual or severe side effects, especially fever, muscle rigidity, confusion, or changes in heart rhythm, to your doctor immediately.
- Be aware of potential weight gain and metabolic changes; discuss lifestyle modifications with your doctor.
- Attend regular follow-up appointments and laboratory monitoring as advised by your doctor.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Amisulpride can cause drowsiness, dizziness, sedation, and blurred vision, especially at the beginning of treatment or after dose changes. These effects may impair your ability to concentrate and react. Therefore, avoid driving or operating heavy machinery until you are certain that this medicine does not adversely affect your ability to perform such tasks.
Lifestyle Advice
- Maintain a healthy and balanced diet and engage in regular physical activity to manage potential weight gain and metabolic changes.
- Avoid exposure to extreme temperatures as amisulpride can affect body temperature regulation, increasing the risk of heatstroke or hypothermia.
- Practice good sleep hygiene to help manage insomnia or sedation.
- Avoid smoking, as it can affect the metabolism of some antipsychotics, though less so for amisulpride.
- Consider stress reduction techniques to complement your treatment.
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Global Brand Names
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